Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages > 70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Cytologically or histologically proven NSCLC(adenocarcinoma, epidermoid carcinoma,large-cell carcinoma) of stage IV with histologically or cytologically proven pleurisyor neoplastic pericarditis.
- No previous systemic chemotherapy for lung cancer.
- Presence of at least one measurable target lesion (RECIST rules) in a non irradiatedregion.
- Age strictly at least 70 years.
- PS 0, 1 or 2.
- Life expectancy sup 12 weeks.
- Creatinine clearance at least 45 ml per min with MDRD Formula (Modification in theDiet in Renal Disease).
- Normal hematologic function: absolute polymorphonuclear neutrophil count > 1.5 . 109per l and or platelets sup 100 . 109/l, hemoglobin sup 9.5 g per dl
- Normal hepatic function: bilirubin inf 1.5 x normal, SGOT and SGPT inf 2.5 . normal.
- Patients with metastatic relapse (cytologically or histologically proven) of primarylung cancer in a non irradiated region, after surgical excision or local externalradiotherapy.
- Prior irradiation is authorized if it involved less than 25 percent of the total bonemarrow volume.
- Men must be surgically sterile or must accept the use of an effective contraceptivemethodall along and until 6 months after the treatment period
- Signed written informed consent.
Exclusion
Exclusion Criteria:
- Other severe concurrent disorders that occurred during the prior six months beforeenrollment (myocardial infection, severe or unstable angor, coronarian or periphericarterial bypass operation, NYHA class 3 or 4 congestive heart failure, transient orconstituted cerebral ischemic attack, at least grade 2 peripheral neuropathy, stomachulcer, erosive oesophagitis or gastritis, psychiatric or neurological disorderspreventing the patient from understanding the trial, uncontrolled infections).
- Another previous or concomitant cancer, except for basocellular cancer of the skin ortreated cervical cancer in situ, or appropriately treated localized lowgrade prostatecancer (Gleason score inf 6), unless the initial tumor was diagnosed and definitivelytreated more than 5 years previously, with no evidence of relapse.
- Bronchoalveolar or neuroendocrine or composite cancers
- Superior caval syndrome.
- Presence of symptomatic brain metastases.
- Peripheral neuropathies (grade sup 2).
- Performance status sup 2 (ECOG).
- A significant third liquid part (for example ascitis or pleural effusion) hat can't becontrolled with drainage or other procedures before enrollment
- Impossibility to stop a treatment by aspirin (if the dose is more than 1.3 mg per day)or NSAI during 5 days (8 days for molecules with long period action like piroxicam
- Concurrent participation in another clinical trial.
- Definitive contraindication to steroids or folic acid and vitamin B12 if histology isnon-epidermoid.
- All concurrent radiotherapy, except for local palliative bone radiotherapy.
- Concurrent administration of one or several other antitumor therapies. Recentvaccination for yellow fever (during the 30 days before enrollment)
- Psychological, familial, social or geographic difficulties preventing follow-up asdefined by the protocol.
- Administrative or legal detention.
- Contraindication to the study drugs.
- Concurrent participation in another clinical trial
Study Design
Connect with a study center
CH du Pays d'Aix
Aix en Provence,
FranceSite Not Available
CHU Amien Picardie
Amiens,
FranceSite Not Available
Centre Hospitalier Universitaire d'Angers
Angers,
FranceSite Not Available
Centre Hospitalier d'Annecy
Annecy,
FranceSite Not Available
Centre Hospitalier Général de la Fontonne Antibes
Antibes,
FranceSite Not Available
CH de Bastia
Bastia,
FranceSite Not Available
Centre Hospitalier de Beauvais
Beauvais,
FranceSite Not Available
CHU Bordeaux Hôpital Haut Lévêque
Bordeaux Pessac,
FranceSite Not Available
Centre Hospitalier Universaitaire de Brest
Brest,
FranceSite Not Available
HIA Tonnerre
Brest,
FranceSite Not Available
Centre François Baclesse
Caen,
FranceSite Not Available
CH René Dubos - Pontoise
Cergy Pontoise,
FranceSite Not Available
Centre Hospitalier Charleville mézières
Charleville Mézières,
FranceSite Not Available
Centre Hospitalier Charleville mézières
Charleville Mézières,
FranceSite Not Available
CHI Créteil
Créteil,
FranceSite Not Available
CHI Créteil
Créteil,
FranceSite Not Available
Centre hospitalier de Draguignan
Draguignan,
FranceSite Not Available
Centre Hospitalier de Elbeuf
Elbeuf,
FranceSite Not Available
CH Gap
Gap,
FranceSite Not Available
CH La Roche sur Yon
La Roche sur Yon,
FranceSite Not Available
Hôpital A Mignot Le Chesnay
Le Chesnay,
FranceSite Not Available
Centre Omar Lambret
Lille,
FranceSite Not Available
Hôpital du Cluzeau
Limoges,
FranceSite Not Available
CHR Longjumeau
Longjumeau,
FranceSite Not Available
Centre Hospitalier de Bretagne Sud
Lorient,
FranceSite Not Available
Hôpital de la Croix Rousse
Lyon,
FranceSite Not Available
Centre Hospitalier
Mantes La Jolie,
FranceSite Not Available
Hôpital Sainte Marguerite
Marseille,
FranceSite Not Available
Institut Paoli-Calmette
Marseille,
FranceSite Not Available
Centre Hospitalier
Martigues,
FranceSite Not Available
Hôpital Saint Farron
Meaux,
FranceSite Not Available
Centre Hospitalier de Mulhouse
Mulhouse,
FranceSite Not Available
CHR Orléans
Orléans,
FranceSite Not Available
CHR Orléans
Orléans,
FranceSite Not Available
Paris Hôpital saint Antoine
Paris,
FranceSite Not Available
Centre Catalan
Perpignan,
FranceSite Not Available
Centre Hospitalier de Périgueux
Périgueux,
FranceSite Not Available
Centre Hospitalier de Périgueux
Périgueux,
FranceSite Not Available
Rennes Hospital University
Rennes, 35033
FranceSite Not Available
CHU Rouen Hôpital Boisguillaume
Rouen,
FranceSite Not Available
Hôpital Charles Nicolle
Rouen,
FranceSite Not Available
CHU Saint Etienne - Hôpital Nord
Saint Etienne,
FranceSite Not Available
Centre Hospitalier Général Salon de Provence
Salon de Provence,
FranceSite Not Available
Institut de Cancérologie de la Loire
St Priest en Jarez,
FranceSite Not Available
Hôpital Font-Pre
Toulon,
FranceSite Not Available
Hôpital d'Instruction des Armées
Toulon Naval,
FranceSite Not Available
CHU Touloues
Toulouse,
FranceSite Not Available
Centre Hospitalier De Villefranche sur Saone
Villefranche sur Saone,
FranceSite Not Available
Hôpital Yves Le Foll
saint Brieuc,
FranceSite Not Available
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